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NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Other Events

NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Other Events

Item 8.01. Other Events.

On June 8, 2017, NewLink Genetics Corporation, a Delaware
corporation, or the Company, issued a press release titled
“NewLink Genetics to Regain Rights to GDC-0919.”
A copy of the press release and the GDC-0919 update slide deck
are attached hereto as Exhibit 99.1 and 99.2, respectively, and
are incorporated herein by reference.
Under the Companys License and Collaboration Agreement dated
October 14, 2014 with Genentech, a member of the Roche Group, or
the Genentech Agreement, the termination of Genentechs rights to
GDC-0919 will become effective 180 days after the Company
receives formal notice from Genentech. Upon such termination,
Genentech will grant to the Company an exclusive, worldwide,
royalty-bearing, sublicensable license, under certain Genentech
intellectual property, to research, develop, manufacture and
commercialize GDC-0919, and the Company will be required to pay a
low single-digit royalty to Genentech on any sales of GDC-0919,
should the Company proceed to develop and commercialize that
compound. Genentech is obligated to transfer the Investigational
New Drug Application for GDC-0919 to the Company and to assign to
the Company all data arising from the studies that Genentech
conducted on GDC-0919. The Company has the right to purchase
Genentechs existing inventory of GDC-0919 at cost. At the
Companys request, Genentech is obligated to supply the Company
with GDC-0919 for one year after termination and to facilitate
the Companys efforts to obtain an alternative source of supply
for GDC-0919. Genentech will be responsible for all costs of
winding down the clinical trials for GDC-0919 that Genentech was
conducting at the time of termination.
Section 9 – Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number
Description
99.1
Press Release, dated June 8, 2017, entitled NewLink
Genetics to Regain Rights to GDC-0919
99.2
GDC-0919 Update Slide Deck

About NewLink Genetics Corporation (NASDAQ:NLNK)
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing immunotherapeutic products for cancer treatment. The Company’s portfolio includes biologic and small-molecule immunotherapy product candidates for a range of oncology indications. Its biologic product candidates are based on its HyperAcute immunotherapy technology platform, which is designed to stimulate the human immune system. Algenpantucel-L is its clinically advanced product candidate for patients with pancreatic cancer. Its additional HyperAcute cellular HyperAcute Cellular Immunotherapy product candidates in clinical development include tergenpumatucel-L and dorgenmeltucel-L for patients with advanced lung cancer and melanoma. It has two small-molecule product candidates in clinical development: GDC-0919 and indoximod. These product candidates are indoleamine-2, 3-dioxygenase (IDO) pathway inhibitors and focus on breaking the immune system’s tolerance to cancer.

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